Manufacturing Engineer

Job Title : Manufacturing Engineer

Job Summary

We are seeking a highly motivated Medical Device Manufacturing Engineer with 4+ years of experience to join our dynamic team.

The ideal candidate will play a key role in improving manufacturing processes, ensuring product quality, and maintaining compliance with regulatory standards such as FDA and ISO.

This role offers the opportunity to contribute to the production of cutting-edge medical devices that enhance patient care and outcomes.

Key Responsibilities

• Manufacturing Process Improvement : Analyze and optimize manufacturing processes for medical device production to enhance efficiency, product quality, and cost-effectiveness.
• Process Validation & Documentation : Perform and document process validations (IQ, OQ, PQ) to ensure compliance with FDA and ISO regulations.
• Lean Manufacturing & Continuous Improvement : Lead continuous improvement initiatives using Lean Six Sigma principles to reduce waste, increase efficiency, and improve process reliability.
• Cross-functional Collaboration : Work closely with R&D, Quality, Regulatory, and Supply Chain teams to ensure seamless transition of new products from design to production.
• Root Cause Analysis & Troubleshooting : Investigate and resolve manufacturing issues using root cause analysis tools such as 8D, 5 Whys, or Fishbone diagrams.
• Equipment & Tooling Design : Design and develop tooling, fixtures, and equipment to support manufacturing operations and new product introductions (NPI).
• Quality Control : Ensure that manufacturing processes comply with quality control standards and product specifications.

Support CAPA activities to address quality issues.

• Regulatory Compliance : Maintain compliance with medical device regulations such as FDA 21 CFR Part 820, ISO 13485, and other relevant standards.
• Supplier Management : Collaborate with suppliers to ensure the quality and timely delivery of components and materials.

Conduct supplier audits as needed.

Data Analysis & Reporting : Collect and analyze production data to identify trends and recommend improvements. Prepare reports on manufacturing performance metrics.

Qualifications & Requirements

• Education : Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or a related field.
• Experience :
• 4+ years of experience in manufacturing engineering, preferably within the medical device or regulated industry.
• Experience with FDA and ISO standards (e.g., ISO 13485, ISO 9001) is required.

Skills :

• Proficient in CAD software (SolidWorks, AutoCAD) for tooling and equipment design.
• Strong problem-solving skills and experience with root cause analysis.
• Familiarity with process validation (IQ, OQ, PQ) and documentation in a regulated environment.
• Hands-on experience with Lean Manufacturing, Six Sigma, or other continuous improvement methodologies.
• Excellent communication and collaboration skills to work effectively with cross-functional teams.
• Ability to manage multiple projects and meet deadlines in a fast-paced environment.
• Certifications : Lean Six Sigma Green Belt (preferred), CQE, or PMP certification is a plus.
• Technical Skills : Experience with ERP systems and proficiency in Microsoft Office (Excel, Word, PowerPoint).

Preferred Experience

• Experience in new product introduction (NPI) within the medical device industry.
• Knowledge of GMP, FDA, and other regulatory requirements.
• Understanding of process automation and robotics is a plus.
4 hours ago